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Recall -- Firm Public Notice

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Lipitor Recall Information

Pfizer recalled specific bottles of LIPITOR (40 mg only) due to a small number of reports of an uncharacteristic odor related to the bottles in which LIPITOR is packaged. A medical assessment has determined that the odor is not likely to cause adverse health consequences in patients taking LIPITOR. There is no need to take any action if you take LIPITOR; please continue to take your medication as prescribed by your doctor. However, if you take LIPITOR 40 mg and experience an uncharacteristic odor associated with your medication, please return the tablets to your pharmacist.

Pfizer is committed to the safety of patients who take our medicines. Pfizer is working closely with the bottle supplier to determine the cause of the odor problem and to rapidly address it. Pfizer responded rapidly to ensure LIPITOR continues to meet the company’s high quality standards. We will continue to actively monitor the situation and take any action necessary to ensure patient safety and maintain the quality of our products.

If you have any questions about LIPITOR, please contact your doctor or your pharmacist or call 1-888-LIPITOR.

Common Questions

Why was LIPITOR recalled?Pfizer has recalled specific “lots” or batches of LIPITOR (40 mg only) due to a small number of reports of an uncharacteristic odor related to the bottles in which the product is packaged. Pfizer is working closely with the bottle supplier to determine the cause of the odor problem and to rapidly address it.

Where can people go for more information about the recall?If you have any questions about the recall please call 1-888-LIPITOR. If you have specific questions about your medication, you may also call your doctor or pharmacist.

I take LIPITOR. What should I do?Pfizer recalled only specific bottles of LIPITOR 40 mg due to a small number of reports of an uncharacteristic odor and a medical assessment has determined that the odor is not likely to cause adverse health consequences in patients taking LIPITOR. Medication should always be taken as prescribed by a doctor. If you take LIPITOR 40 mg and experience an uncharacteristic odor associated with your medication, please return the tablets to your pharmacist.

If you take LIPITOR and experience an odd smell or odor, what should you do? Pfizer recalled only specific bottles of LIPITOR 40 mg due to a small number of reports of an uncharacteristic odor and a medical assessment has determined that the odor is not likely to cause adverse health consequences in patients taking LIPITOR. If you take LIPITOR 40 mg and experience an uncharacteristic odor associated with your medication, please return the tablets to your pharmacist. If you have any concerns, call your doctor or pharmacist or call 1-888-LIPITOR if you need any further information.

Is it still safe to take LIPITOR?Pfizer has recalled only specific bottles of LIPITOR 40 mg due to a small number of reports of an uncharacteristic odor related to the bottles in which LIPITOR is packaged. A medical assessment has determined the odor is not likely to cause adverse health consequences in patients taking LIPITOR. Pfizer remains confident in the safety and efficacy of LIPITOR.

Will there be a LIPITOR 40 mg shortage as a result of the recall?Pfizer has taken a number of steps to ensure that there is no shortage of LIPITOR 40 mg as a result of this recall.

Can I get a refund if I take LIPITOR 40 mg?Pfizer has recalled only specific bottles of LIPITOR 40 mg. Please speak to your pharmacist about refund policies. Pfizer is not offering a refund.